Minoxidil Dose Response Study in Females Identified Through IVD Testing as

Status Withdrawn

Clinical Trial Summary

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.

The primary purpose of this study is to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

Clinical Trial Description

Approximately, 40% of women suffer from female pattern hair loss by the age of 55. Currently, there is only one drug approved by the US FDA for the treatment of female pattern hair loss (AGA) - topical minoxidil.

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female AGA. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.

Minoxidil is a pro-drug. To elicit a clinical response, minoxidil must be converted to its active form minoxidil sulfate by a sulfotransferase enzyme found in hair follicles. The investigators have developed an in-vitro diagnostic test that correctly identifies, prior to initiating therapy, 95.9% of non-responders to 5% topical minoxidil. The diagnostic test analyzes the sulfotransferase enzymatic activity in hair follicles to determine if a sufficient amount of minoxidil will be converted to the active form required to induce hair growth. Subjects with low enzymatic activity experience little or no therapeutic benefit and a reduced frequency of adverse events.

Consequently, the investigators hypothesize that in subjects with low enzymatic activity (i.e., low minoxidil metabolizers) an increased minoxidil dosage will elicit a therapeutic response with little or no increase in the frequency of adverse events. It is thus the primary purpose of this study to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02486848
Study type	Interventional
Source	Applied Biology, Inc.
Contact
Status	Withdrawn
Phase	N/A
Start date	June 2016
Completion date	December 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms